Demodex Blepharitis Treatment Study (DBTS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial|
- Eradication of Demodex Mites [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Reduction in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".
- Change in Lid Margin redness and Bulbar Conjunctival Hyperemia [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
Lid margin redness and bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). Hyperemia will be graded on the following scale and half scores are acceptable:
- None (0) = normal
- Mild (1) = Slight localized injection
- Moderate (2) = pink color
- Severe (3) = dark redness
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Terpinen-4-ol Treatment Arm
30 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (15 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Lid scrub once or twice per day for one month.
Other Name: T4O
Placebo Comparator: Placepo Pads Contol Arm
30 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (15 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Lid scrub once or twice per day for one month
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647217
|Contact: Hosam El Sheha, MD, PhDemail@example.com|
|United States, Florida|
|Ocular Surface Center||Recruiting|
|Miami, Florida, United States, 33173|
|Contact: Hosam El Sheha, MD, PhD|
|Principal Investigator: Scheffer CG Tseng, MD, PhD|
|Sub-Investigator: Hosam El Sheha, MD, PhD|
|Study Chair:||Scheffer CG Tseng, MD, PhD||Tissue Tech Inc.|